The following data is part of a premarket notification filed by Spine View, Inc. with the FDA for Spineview X-pac Expandable Lumbar Cage System.
| Device ID | K160856 |
| 510k Number | K160856 |
| Device Name: | SpineView X-Pac Expandable Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 |
| Contact | Mbithi Muthini |
| Correspondent | Nancy Lince Lince Consulting 111 Deerwood Road, Suite 200 San Ramon, CA 94583 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-28 |
| Decision Date | 2016-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853954003203 | K160856 | 000 |
| 00850001720199 | K160856 | 000 |
| 00850001720007 | K160856 | 000 |
| 00850001720021 | K160856 | 000 |
| 00850001720052 | K160856 | 000 |
| 00850001720069 | K160856 | 000 |
| 00850001720076 | K160856 | 000 |
| 00850001720083 | K160856 | 000 |
| 00850001720106 | K160856 | 000 |
| 00850001720113 | K160856 | 000 |
| 00850001720120 | K160856 | 000 |
| 00850001720137 | K160856 | 000 |
| 00850001720168 | K160856 | 000 |
| 00850001720175 | K160856 | 000 |
| 00853954003197 | K160856 | 000 |
| 00850001720564 | K160856 | 000 |